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Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients

Primary Purpose

Acute Otitis Media

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
DF289
DF277
DF289 plus DF277
Sponsored by
Salvat
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Otitis Media focused on measuring with tubes

Eligibility Criteria

6 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 6 months to 12 years
  • ear tube in the ear which will be treated
  • otorrhea for 3 weeks or less
  • moderate or severe otorrhea

Exclusion Criteria:

  • other ear diseases

Sites / Locations

  • Laboratorios SALVAT S.A.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

DF289

DF277

DF289 plus DF277

Arm Description

Ear drops

Ear drops

Ear drops

Outcomes

Primary Outcome Measures

Time to Cessation of Otorrhea

Secondary Outcome Measures

Full Information

First Posted
July 22, 2011
Last Updated
October 3, 2017
Sponsor
Salvat
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1. Study Identification

Unique Protocol Identification Number
NCT01404611
Brief Title
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients
Official Title
A Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution Compared to DF289 Otic Solution and to DF277 Otic Solution in the Treatment of Acute Otitis Media With Tympanostomy Tubes (AOMT) in Pediatric Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Salvat

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine if a combination of an antibiotic plus a corticosteroid is safe and effective in treating middle ear infections in children with ear tubes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Otitis Media
Keywords
with tubes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
331 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DF289
Arm Type
Active Comparator
Arm Description
Ear drops
Arm Title
DF277
Arm Type
Active Comparator
Arm Description
Ear drops
Arm Title
DF289 plus DF277
Arm Type
Experimental
Arm Description
Ear drops
Intervention Type
Drug
Intervention Name(s)
DF289
Intervention Description
Ear drops
Intervention Type
Drug
Intervention Name(s)
DF277
Intervention Description
Ear drops
Intervention Type
Drug
Intervention Name(s)
DF289 plus DF277
Intervention Description
Ear drops
Primary Outcome Measure Information:
Title
Time to Cessation of Otorrhea
Time Frame
From baseline until the end of the study (up to 22 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 6 months to 12 years ear tube in the ear which will be treated otorrhea for 3 weeks or less moderate or severe otorrhea Exclusion Criteria: other ear diseases
Facility Information:
Facility Name
Laboratorios SALVAT S.A.
City
Esplugues de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
28006041
Citation
Spektor Z, Pumarola F, Ismail K, Lanier B, Hussain I, Ansley J, Butehorn HF 3rd, Esterhuizen K, Byers J, Douglis F, Lansford B, Hernandez FJ. Efficacy and Safety of Ciprofloxacin Plus Fluocinolone in Otitis Media With Tympanostomy Tubes in Pediatric Patients: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2017 Apr 1;143(4):341-349. doi: 10.1001/jamaoto.2016.3537.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients

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